biosimilar
noun
bio·sim·i·lar
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Medical Definition of biosimilar
: a substance of biological origin (such as a globulin, vaccine, or hormone) that is used in the prevention or treatment of disease and is highly similar to a previously-approved proprietary biologic
Note: Biosimilars must be found to have no clinically significant difference to the previously-approved biologic and only vary in their clinically inactive components.
Under the BPCI Act, biosimilars will also have the opportunity to meet a higher standard of similarity to a reference product—"interchangeability," reflecting an FDA assessment that pharmacists can make substitutions between biologics without the prescriber's intervention.— Steven Kozlowski et al., The New England Journal of Medicine, 4 Aug. 2011Other Words from biosimilar
biosimilar
adjective
biosimilar drugs
biosimilarity
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noun
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noun
A demonstration of biosimilarity will have to include analytical data, animal testing and one or more clinical studies, unless such a requirement is determined by the FDA to be unnecessary.
— Robert Cohen, The Star-Ledger (Newark, New Jersey), 28 June 2007